A Study to Find a Suitable Dose of Exl-111 for Further Research
Recruiting
Phase 1
Interventional Study
Allergic Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- Excellergy Inc. · Industry
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About This Trial
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants.
The trials consists of 2 parts, as follows:
Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo.
Part B (MAD): Up to 3 dose cohorts, each with 10 participants, randomized into 3 arms: Exl-111, placebo,…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Healthy, male and female participants 18-55 years of age at Screening
2. Body weight ≥45 kg and ≤120 kg and body mass index (BMI) 18 to ≤32 kg/m2 at Screening and Day -1
3. Serum IgE ≥30 IU/mL and ≤300 IU/mL at Screening
4. Nonsmoker and must not have used any tobacco product…
Contacts