A Phase I/II Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SUM-191 in Healthy Participants and in Participants With Bacterial Conjunctivitis
Senju USA, Inc.
Summary
This is a seamless Phase I/II, randomized, double-masked, placebo-controlled, multicenter trial to evaluate single and multiple-dose safety and tolerability of SUM-191 in healthy participants in Parts 1 (SAD) and 2 (MAD) ; and multiple-dose efficacy and safety of SUM-191 in participants with bacterial conjunctivitis in Part 3.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. The participant is able to provide signed and dated, written informed consent prior to any trial specific procedures. 2. The participant understands and is able and willing to fully comply with trial procedures and restrictions. 3. The participant is a male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol, or is a female of non-childbearing potential. 4. The male participant must agree not to donate sperm 90 days after last dose of IP and female participant must agree not to donate egg 30 days afte…
Interventions
- DrugSUM-191
Part 1 (SAD): SUM-191 is administrated a single dose topically. Part 2 (MAD): SUM-191 is administrated TID topically for 6 days. Part 3: SUM-191 is administrated TID topically for 6 days.
- DrugPlacebo
Part 1 (SAD): Placebo is administrated a single dose topically. Part 2 (MAD): Placebo is administrated TID topically for 6 days. Part 3: Placebo is administrated TID topically for 6 days.
Location
- Austin Clinical Research UnitAustin, Texas