A Study of LAD106 in Healthy Adult Participants
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAlmirall, S.A.
About this trial
The main aim of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of single ascending doses of LAD106 (Part A) and multiple ascending doses of LAD106 (Part B) in human healthy participants.
Eligibility criteria
Qualifiers
Signed informed consent and willing and able to comply with the study protocol.
Healthy men or women,18 to 45 years of age (inclusive) at screening.
Female participants agree to use effective contraception.
Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women.
Disqualifiers
Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator.
Clinically significant abnormalities, as judged by the Investigator, in laboratory test results.
Use of any medications (prescription or over-the-counter [OTC]), within 14 days prior to IMP dosing or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).
If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.
Trial design
Treatments tested in this trial
- LAD106
- Lebrikizumab
- Placebo
Treatment groups
93 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov