Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • LAD106

    Drug

    LAD106 will be administered.

  • Lebrikizumab

    Drug

    Lebrikizumab will be administered.

  • Placebo

    Other intervention

    Placebo matching LAD106 will be administered.

Treatment groups

93 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Part A: LAD106 (Cohort 1)Experimental treatment 1 intervention
Group B: Part A: LAD106 (Cohort 2)Experimental treatment 1 intervention
Group C: Part A: LAD106 (Cohort 3)Experimental treatment 1 intervention
Group D: Part A: LAD106 (Cohort 4)Experimental treatment 1 intervention
Group E: Part A: LAD106 (Cohort 5)Experimental treatment 1 intervention
Group F: Part A: LAD106 (Cohort 6)Experimental treatment 1 intervention
Group G: Part A: PlaceboPlacebo comparator 1 intervention
Group H: Part B: LAD106 (Cohort A)Experimental treatment 1 intervention
Group I: Part B: LAD106 (Cohort B)Experimental treatment 1 intervention
Group J: Part B: LAD106 (Cohort C)Experimental treatment 1 intervention
Group K: Part B: Lebrikizumab (Cohort 0)Active comparator 1 intervention
Group L: Part B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs

Time frame
From start of study drug up to follow-up (Day 81)
2

Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs

Time frame
From start of study drug up to follow-up (Day 104)

Secondary outcomes

1

Part A (SAD) and B (MAD): LAD106 Serum Concentrations Over Time

Time frame
Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
2

Part A (SAD) and B (MAD): Maximum Serum Concentration (Cmax) of LAD106

Time frame
Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
3

Part A (SAD) and B (MAD): Time to Reach Maximum Serum Concentration (tmax) of LAD106

Time frame
Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
4

Part A (SAD) and B (MAD): Area Under the Serum Concentration-time Curve (AUC) of LAD106

Time frame
Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Almirall, S.A.

Lead sponsor

Source ClinicalTrials.gov
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