A Phase 1 Randomized, Placebo-Controlled, Double-Blind, First- Time-in-Humans, Single-Ascending Dose (SAD) and Multiple- Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CNM-Au8 in Healthy Male and Female Volunteers

Completed

• Conditions: nerve disease; Neuromyelitis optica; 10012303

• Registration Number: NL-OMON42813
• Lead Sponsor: Clene Nanomedicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
2. Is between the ages of 18 and 45 years, inclusive.
3. Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agree, from the time of signing the informed consent or 14 days prior to check-in until 30 90 days after Study Completion/Discharge, to use two forms of contraception.
4. Has a body mass index (BMI) between 18 and 34 kg/m2.
5. All laboratory values at screening fall within normal range or are evaluated as not clinically significant (NCS) by the Investigator if outside normal range.
6. Has no clinically significant abnormal findings during pre-dose physical examination or
Screening and Baseline vital signs or ECG.
7. Has not consumed and agrees to abstain from taking any dietary supplements or non- prescription drugs (except as authorized by the Investigator AND Medical Monitor) for 3 days prior to CRU admission through Follow-Up.
8. Has not consumed and agrees to abstain from taking any prescription drugs (except as authorized by the Investigator AND Medical Monitor) during the 14 days prior to CRU admission through Follow-Up.
9. Has not consumed alcohol-containing beverages for starting 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up.
10. Has not consumed grapefruit or grapefruit juice within the 14 days prior to CRU
admission and agrees not to consume grapefruit or grapefruit juice through Follow-Up.
11. Has not used tobacco- and nicotine-containing products within 60 days prior to the CRU admission and agrees to abstain from using tobacco- and nicotine-containing products through Follow-Up.
12. Has the ability to understand the requirements of the study and is willing to comply with all study procedures.

Exclusion Criteria

1. Has a history of illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
2. Has positive findings on urine drug screen.
3. Is positive for human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C on screening assessments.
4. Is pregnant or lactating.
5. Has clinically significant medical or psychiatric history that, in the Investigator*s judgment, would compromise the subject*s safety or the collection of data.
6. Has donated plasma within 7 days of CRU admission.
7. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
8. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified