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Trial on Single/Multiple Ascending Doses for Safety, PK and PD for CBP-0276 in Healthy Subjects

NCT07708831 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-07-16

No results posted yet for this study

Summary

A double-blind, randomized, placebo-controlled, single and multiple ascending dose study with food effect to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CBP-0276. Incidence of potential related adverse events and laboratory abnormalities produced after investigational product vs. placebo administration will be identified and analyzed. 64 subjects in total, 32 subjects in Part 1 (Single Dose Ascending:SAD) and 32 subjects in Part 2 (Multiple Dose Ascending:MAD). Healthy voluntieers (male and women), ≥ 18 to ≤ 64 years with at least least 50% of the population ≥ 45 years old will be included after sign of informed consent. Full sample in SAD and MAD will be divided in 4 subcohorts each. Subcohorts will receive 100mgQD of CBP-0276 or placebo (6:2), 200mgQD of CBP-0276 or placebo (6:2), 200mgBID of CBP-0276 or placebo (6:2) or 400mg QD of CBP-0276 or placebo (6:2). On MAD subjects will receive CBP-0276 during 14 days. The total duration of study participation for each subject (from the screening visit to the end-of-study visit) on SAD will be approximately 36 days for cohorts S1, S3, and S4 and approximately 43 days for cohort S2. The total duration of study participation for each subject (from the screening visit to the end-of-study visit) on MAD will be approximately 49 days for the M1, M2, M3, and M4 cohorts. After CBP-0276 administration plasma samples will be obtained to evaluate PK parameteres (AUC0-∞, AUC0-24, AUC0-tlast, AUC0-τ, %AUCextrap, Cmax, Ctrough, tlag, tmax.ss, t1/2, λz, MRT0-∞, CL/F, Vz/F, %Fluctuation, ARABC and ARCmax in plasma).

Conditions

  • Healthy Volunteers

Interventions

DRUG

Placebo for CBP-0276 Acetate

Placebo for CBP-0276 Acetate: 100 mg of microcrystalline cellulose microcrystals (MCC)

DRUG

CBP-0276 Acetate

CBP-0276 Acetate

Sponsors & Collaborators

  • Clarent Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Juan MA Garcia Lara, MD, MSc · Innovación y Desarrollo en Ciencias de la Salud SRL de CV

  • Omar Cárdenas Sáenz, MD, MSc · Centro de Investigación Clínica y Medicina Translacional (CIMeT)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
63 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2026-02-16
Completion
2026-04-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708831 on ClinicalTrials.gov