Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks

NCT05597462 | Completed Phase 1 FDA Drug

• 1 other identifier: DFD-29-CD-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this trial is to evaluate the effects of 16-week treatment with DFD-29 40 mg QD dose in comparison to Placebo on the skin, intestinal and vaginal microbiota.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (2)

• Changes in the number of colony forming units (CFUs) of microbial species.

  Change in the colony forming units (CFUs) of microbial species colonized from skin, gastrointestinal or vaginal swabs from Baseline (BL) to Week 16 in comparison of DFD-29 versus Placebo treatment groups

  Baseline to Week 16

• Changes in MIC90 of selected colonized microbial species.

  Changes in MIC90 of the selected colonized microbial species to minocycline in the comparison of DFD-29 group versus Placebo treatment groups.

  Baseline to Week 16.

Study Arms (2)

DFD-29

EXPERIMENTAL

DFD-29 (minocycline hydrochloride) capsules, 40 mg will be administered orally once daily for 16 weeks.

Drug: Minocycline hydrochloride capsules

Placebo

PLACEBO COMPARATOR

Placebo capsules will be administered orally once daily for 16 weeks.

Other: Placebo

Interventions

Minocycline hydrochloride capsules DRUG

Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks.

Also known as: DFD-29

DFD-29

Placebo OTHER

Placebo capsules will be administered orally once daily for 16 weeks.

Also known as: Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female aged ≥ 18 and ≤ 65 years.
• Subjects must have understood, and signed IRB/IEC approved written ICF.
• Subjects must be willing to refrain from using all other antibiotics during the 16-week treatment period, other than the IP.
• Women of childbearing potential\* must not be pregnant or lactating at the time of screening visit as documented by a negative urine pregnancy test.
• Women of childbearing potential must be willing to use an acceptable form of birth control during the trial from the day of the first dose administration to 30 days after the last administration of trial drug.
• All male subjects must agree to use accepted methods of birth control with their partners, throughout the study and until 30 days after the last administration of trial drug.
• Subjects must be in good health and free from any clinically significant disease, which may interfere with the evaluation of microbiota or the administration of the IP.

You may not qualify if:

• Female subjects who are pregnant, lactating or planning to become pregnant during trial participation.
• History of allergy or known sensitivity to minocycline, doxycycline, other tetracycline, or any component of the study medication.
• Clinically significant abnormal laboratory test results that, in the opinion of the Investigator, would compromise the subject's safety or ability to participate in the trial
• History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
• History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
• Any clinically significant condition that, in the opinion of the Investigator, would interfere with the study evaluations or would place the trial subject at undue safety risk.
• Subjects with an active acute or chronic systemic infections
• Subjects with planned surgery during the trial or within 30 days after the last dose administration
• Subjects who cannot avoid excessive exposure to UV radiation (use of tanning booths or extended /occupational exposure to sunlight)
• Subjects that have a medical history of photosensitivity or hyperpigmentation
• Female subjects with medical history within 3 months prior to randomization of having vaginitis or that use a vaginal douche or vaginal cleaning agent within 48 hours of any visit
• Subjects who used the following
• Non-tetracycline antibiotics (systemic) within 6 weeks prior to Baseline (BL)
• Tetracycline antibiotics (systemic) within 3 months prior to BL
• Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates) within one year prior to screening

Sponsors & Collaborators

• Journey Medical Corporation: lead
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (2)

3A Research, LLC

Las Cruces, New Mexico, 88011, United States

Location

3A Research, LLC

El Paso, Texas, 79925, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Srinivas Sidgiddi, M.D.

  Journey Medical Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-center, randomized, double-blind, placebo-controlled, parallel group trial with a treatment period of 16 weeks.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 28, 2022
• Study Start: September 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Before database lock for the study

Locations

US (2)