Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6

NCT07170189 | Completed Phase 1 FDA Drug

• 1 other identifier: RIV-HU6-108
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for HU6 450 mg once daily (QD) dose (as single or multiple tablets) or HU6 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD.

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

• b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax).

  To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on exposure parameters of maximum concentration (Cmax), after multiple dose administration of the tablet and capsule formulations of HU6

  28 days

Study Arms (5)

Experimental: Active Treatment HU6 450 mg tablet

EXPERIMENTAL

Drug: HU6 450 mg single tablet once daily (QD)

Drug: HU6

Experimental: Active Treatment HU6 150 mg x 3 tablets

EXPERIMENTAL

Drug: HU6 150 mg x 3 tablets QD

Drug: HU6

Experimental: Active Treatment HU6 (150 mg tablet × 2) BID

EXPERIMENTAL

Drug: HU6 300 mg dose (supplied as HU6 150 mg tablet × 2) BID (q12 hours)

Drug: HU6

Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total)

EXPERIMENTAL

Drug: HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD

Drug: HU6

Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total)

EXPERIMENTAL

Drug: HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD

Drug: HU6

Interventions

HU6 DRUG

HU6 tablet or capsule

Experimental: Active Treatment HU6 (150 mg tablet × 2) BID; Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total); Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total); Experimental: Active Treatment HU6 150 mg x 3 tablets; Experimental: Active Treatment HU6 450 mg tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 55 years of age at time of signing the informed consent.
• Body mass index (BMI) ≥ 25 kg/m2 at Screening.
• Medically stable in the opinion of the investigator based on medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
• Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this clinical protocol.

You may not qualify if:

• Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease as determined by the investigator and if deemed necessary, in consultation with the medical monitor, which may impact safety.
• History of cancer (except for treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
• Any surgical or medical condition or history that, in the opinion of the investigator, and if deemed necessary, in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of IMP, such as, but not limited to, gastric bypass surgery or gallbladder removal surgery or significant small bowel resections.
• Contraindication to IMP or its excipients and/or history of anaphylactic reactions or clinically significant allergic reaction.

Sponsors & Collaborators

• Rivus Pharmaceuticals, Inc.: lead

Study Sites (1)

Nucleus Network

Minneapolis, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: October 13, 2025
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)