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

A Phase 1, Open-label, Randomized, Five-Part Study to Assess the Pharmacokinetics and Safety of Tablet and Capsule Formulations of HU6 in Overweight Participants.

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Drug: HU6

Detailed Description

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 450 mg once daily (QD) dose (as single or multiple tablets) or 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. Population pharmacokinetic (popPK) modeling indicated a potential difference in PK profile when multiple dose units are administered versus a single dose unit in tablet and capsule formulations.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55114
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Active Treatment HU6 450 mg tablet; Drug: HU6 450 mg single tablet once daily (QD)	Drug: HU6; HU6 tablet or capsule
Experimental: Experimental: Active Treatment HU6 150 mg x 3 tablets; Drug: HU6 150 mg x 3 tablets QD	Drug: HU6; HU6 tablet or capsule
Experimental: Experimental: Active Treatment HU6 (150 mg tablet × 2) BID; Drug: HU6 300 mg dose (supplied as HU6 150 mg tablet × 2) BID (q12 hours)	Drug: HU6; HU6 tablet or capsule
Experimental: Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total); Drug: HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD	Drug: HU6; HU6 tablet or capsule
Experimental: Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total); Drug: HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD	Drug: HU6; HU6 tablet or capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rivus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Actual): December 4, 2025
• Study Completion (Actual): December 4, 2025

Study Registration Dates

• First Submitted: September 5, 2025
• First Submitted That Met QC Criteria: September 5, 2025
• First Posted (Actual): September 12, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight
• Other Study ID Numbers: RIV-HU6-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No