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

Topokine Therapeutics

Status and phase: Completed; Phase 1

Conditions: Nasolabial Folds; Lipoatrophy; Lipodystrophy

Treatments: Drug: Placebo; Drug: TAT4 Gel concentration B; Drug: TAT4 Gel concentration A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02647853

TAT4 A1

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 3 patient groups, including a placebo group

TAT4 Gel concentration A

Experimental group

Description:

TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days.

Treatment:

Drug: TAT4 Gel concentration A

TAT4 Gel concentration B

Experimental group

Description:

TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days.

Treatment:

Drug: TAT4 Gel concentration B

Placebo

Placebo Comparator group

Description:

Placebo product once daily to 50 cm2 for 14 days.

Treatment:

Drug: Placebo