Recruitment

Recruitment Status
Completed
Estimated Enrollment
48

Inclusion Criteria

Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
...
Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR
Cohorts 1, 2 & 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR
Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly
If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729
Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent.
Have a 12-lead ECG recording consistent with normal cardiac function
Vital sign assessments within normal ranges

Exclusion Criteria

Preplanned surgery or procedures that would interfere with the conduct of the study.
Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.
Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
...
Preplanned surgery or procedures that would interfere with the conduct of the study.
Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.
Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV1729.
History of regular alcohol consumption within 6 months of the study.
Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
Subjects known to suffer from hayfever, or other allergy, that may require antihistamine therapy during the course of the study.
Any other reason that the Investigator considers makes the subject unsuitable to participate.
History of clinically significant allergies that, in the opinion of the Investigator or Medical Monitor, would contraindicate their participation.
Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection or hepatitis C antibodies.
If a woman has a positive serum pregnancy test at screening or a positive urine pregnancy test on Day -1, is pregnant, breast-feeding or planning to become pregnant during the study.
Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1
Subject is mentally or legally incapacitated.
The subject is unable or unwilling to comply fully with the study protocol.
Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
Liver function test results >1.5 x ULN (upper limit of normal) at Screening or on Day -1.
Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months or intention to donate blood or blood products during the study.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of smoking or use of nicotine-containing substances within the previous 6 months, or a positive carbon monoxide test at screening or on Day -1 (or a smoking history ≥ 10 pack years).
History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years.
Upper or lower respiratory tract infection within 4 weeks before screening
Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1

Summary

Conditions
  • Asthma
  • Healthy Volunteers
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Inclusion Criteria

Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
...
Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR
Cohorts 1, 2 & 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR
Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly
If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729
Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent.
Have a 12-lead ECG recording consistent with normal cardiac function
Vital sign assessments within normal ranges

Exclusion Criteria

Preplanned surgery or procedures that would interfere with the conduct of the study.
Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.
Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
...
Preplanned surgery or procedures that would interfere with the conduct of the study.
Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.
Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV1729.
History of regular alcohol consumption within 6 months of the study.
Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
Subjects known to suffer from hayfever, or other allergy, that may require antihistamine therapy during the course of the study.
Any other reason that the Investigator considers makes the subject unsuitable to participate.
History of clinically significant allergies that, in the opinion of the Investigator or Medical Monitor, would contraindicate their participation.
Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection or hepatitis C antibodies.
If a woman has a positive serum pregnancy test at screening or a positive urine pregnancy test on Day -1, is pregnant, breast-feeding or planning to become pregnant during the study.
Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1
Subject is mentally or legally incapacitated.
The subject is unable or unwilling to comply fully with the study protocol.
Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
Liver function test results >1.5 x ULN (upper limit of normal) at Screening or on Day -1.
Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months or intention to donate blood or blood products during the study.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of smoking or use of nicotine-containing substances within the previous 6 months, or a positive carbon monoxide test at screening or on Day -1 (or a smoking history ≥ 10 pack years).
History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years.
Upper or lower respiratory tract infection within 4 weeks before screening
Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1

Tracking Information

NCT #
NCT02140320
Collaborators
Not Provided
Investigators
Study Director: Liza O'Dowd, MD Sponsor GmbH
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