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A Randomised, Placebo-Controlled, Double-Blind, Single-Ascending Dose and Multiple-Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered ALE1 With or Without Food in Healthy Adult Participants and Adult Patients With Hypophosphatasia

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522378-36-00
Acronym
ALE1-101
Enrollment
24
Registered
2025-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypophosphatasia

Brief summary

Number and severity of treatment emergent adverse events (TEAEs) in healthy participants and patients with hypophosphatasia (HPP) with increasing oral doses of ALE1

Detailed description

Pharmacokinetic parameters of single and multiple ascending doses of ALE1., Pharmacodynamic biomarker levels in blood samples of single and multiple ascending doses of ALE1., Dose proportionality in pharmacokinetic parameters in single and multiple ascending doses of ALE1., Effect of food on ALE1 pharmacokinetic parameters.

Interventions

DRUGALE1 I
DRUGALE1
DRUGALE1 matched placebo
DRUGALE1 III

Sponsors

Alesta Therapeutics B.V.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Number and severity of treatment emergent adverse events (TEAEs) in healthy participants and patients with hypophosphatasia (HPP) with increasing oral doses of ALE1—

Secondary

MeasureTime frame
Pharmacokinetic parameters of single and multiple ascending doses of ALE1., Pharmacodynamic biomarker levels in blood samples of single and multiple ascending doses of ALE1., Dose proportionality in pharmacokinetic parameters in single and multiple ascending doses of ALE1., Effect of food on ALE1 pharmacokinetic parameters.—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026