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

A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02647853

Enrollment

Registered

2016-01-06

Start date

2014-10-31

Completion date

2014-12-31

Last updated

2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipoatrophy, Lipodystrophy, Nasolabial Folds

Brief summary

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.

Interventions

DRUGTAT4 Gel concentration A

DRUGTAT4 Gel concentration B

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Adverse Event rates	21 days	Adverse event rates by System Organ Class, as graded by current CTCAE

Secondary

Measure	Time frame
Plasma pharmacokinetics (Cmax)	Days 1 and 13
Plasma pharmacokinetics (Tmax)	Days 1 and 13
Plasma pharmacokinetics (AUC0-24)	Day 1 and 13

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026