Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers

Topokine Therapeutics, Inc.16 enrolled

Overview

This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nasolabial Folds Lipoatrophy Lipodystrophy

Interventions

TAT4 Gel concentration ADRUG

TAT4 Gel concentration BDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women 40-70 years old * Healthy volunteers * Provision of informed consent Exclusion Criteria: * History of skin hypersensitivity * Abnormality on screening assessments

Locations (1)

Topokine Clinical Site

Cypress, California, United States

Outcomes

Primary Outcomes

Adverse Event rates

Adverse event rates by System Organ Class, as graded by current CTCAE

Time frame: 21 days

Secondary Outcomes

Plasma pharmacokinetics (Cmax)

Time frame: Days 1 and 13

Plasma pharmacokinetics (Tmax)

Time frame: Days 1 and 13

Plasma pharmacokinetics (AUC0-24)

Time frame: Day 1 and 13

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.