A Phase 1 trial assessing the Safety, Tolerability, and Pharmacokinetics of NIDO-361 in Healthy Male Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single and Multiple Ascending Doses of NIDO-361 in Healthy Male Subjects
Nido Biosciences, Inc.
64 participants
Aug 28, 2022
Interventional
Conditions
Summary
This study will be investigating the safety and tolerability of NIDO-361 and the amount of NIDO-361 in the body when taken in single and multiple doses in healthy male participants so as to possibly be a treatment in the future for Spinal and bulbar muscular atrophy (SBMA), also known as Kennedy’s Disease. This is a condition that only affects men and causes muscle weakness, tremor, and cramps among other neuromuscular and hormonal symptoms. Kennedy’s Disease is caused by a genetic mutation affecting the androgen receptor, which controls how hormones like testosterone work in the body. It is hoped that in patients with Kennedy’s Disease, NIDO-361 will correct the way the androgen receptor interprets signals from the testosterone re-establishing its normal function. This study will involve the recruitment of 64 healthy male participants between the ages of 18 and 55 years who weigh at least 45kg and have a body mass index between 18-32 kg/m2. There will be 5 cohorts of 8 participating in the single ascending dose part of the study involving a 3 night in house stay and follow-up visit on Day 8 and 3 cohorts of 8 participating in the multiple ascending dose part of the study involving 7 days of consecutive dosing, a 9 night in house stay and follow-up visit on Day 15.
Eligibility
Inclusion Criteria6
- To be included in this study, each individual must satisfy all the following criteria:
- The subject is a healthy male adult, aged 18 to 55 years, inclusive, at the time of consent.
- The subject weighs at least 45 kg (99 lb.) and has a body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
- The subject has documented ability to understand the written study informed consent form (ICF) and consent and has provided signed written informed consent prior to any study procedures.
- A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of the informed consent throughout the duration of the study and 90 days from the last dose. In addition, male subjects must be willing to forgo sperm donation for the duration of the study and 3 months after completion of the study.
Exclusion Criteria4
- If an individual meets any of the following criteria, he is ineligible for this study:
- Use of other investigational drugs within 30 days or 5 half-lives prior to the planned first drug administration, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- Clinically significant cardiovascular, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurologic, immunologic, malignant, metabolic, psychiatric, or other condition that, in the opinion of the Investigator, precludes the subject’s safe participation in the study or would interfere with the study assessments.
- Malignancy or has received treatment for malignancy, other than treatment for basal cell or squamous cell carcinoma of the skin, within the previous 5 years.
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Interventions
This is a randomized, double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted in two parts. Part A: A single ascending dose (SAD) part where dose levels will be evaluated in a sequential manner starting at the proposed lowest dose level in healthy male volunteers. 40 healthy male volunteers will be enrolled in a total of 5 cohorts. Each cohort will enrol 8 participants with 6 participants randomized to receive NIDO-361 and 2 participants randomized to receive placebo. NIDO-361 will be provided as an oral capsule. NIDO-361 dose levels in the range of 75 to 500 mg are planned to be investigated. A single dose of NIDO-361 or placebo will be administered on Day 1 followed by approximately 48 hours of safety, tolerability, and PK assessments. Participants will return approximately 1 week post study check-out to complete follow-up assessments. Part B: A multiple ascending dose (MAD) part where dose levels will be evaluated depending on SAD results in healthy male volunteers. Up to 24 healthy male volunteers will be enrolled in a total of 3 cohorts. Each cohort will enrol 8 participants with 6 participants randomized to receive NIDO-361 and 2 participants randomized to receive placebo. A dose level will only be evaluated in Part B if determined to be safe and tolerable in Part A. NIDO-361 or placebo will be administered daily (QD) for seven days (total of 7 doses) followed by approximately 48 hours of observation after last dose for safety assessments before discharge. Participants will return approximately 1 week post study check-out to complete follow-up assessments. Adherence to the intervention will be done via completion of drug accountability.
Locations(1)
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ACTRN12622000964718