A Phase 1 trial assessing the Safety, Tolerability, and Pharmacokinetics of NIDO-361 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Spinal and bulbar muscular atrophy (SBMA); Neurological - Other neurological disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12622000964718
• Lead Sponsor: ido Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-07
• Study Completion: 2023-03-03
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

To be included in this study, each individual must satisfy all the following criteria:
1.The subject is a healthy male adult, aged 18 to 55 years, inclusive, at the time of consent.
2.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.
3.In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
4.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.
5.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 Criteria

If an individual meets any of the following criteria, he is ineligible for this study:
1.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.
2.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.
3.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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified