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.
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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

Reza Pishva

+61731376258

reza.pishva@novotech-cro.com

CONTACT