Trials Sponsors Conditions Drugs Pricing

Conditions

Hypophosphatasia Hypophosphatasia (HPP)

Keywords

hypophosphatasia

Outcome Measures

Primary Outcomes (5)

Evaluate the safety of ALE1 by assessing the number of treatment emergent adverse events (TEAEs)
From baseline up to day 16
Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants haematology parameters post-dose
From baseline up to day 16
Evaluate safety of ALE1 by assessing the presence of clinically significant changes in participants biochemistry parameters post-dose
From baseline up to day 16
Evaluate safety of ALE1 by assessing changes in heart rhythms via electrocardiogram
From baseline up to day 16
Evaluate safety of ALE 1 by assessing the presence of clinically significiant changes in participants vital signs
From baseline up to day 16

Secondary Outcomes (10)

Pharmacokinetic parameter: area under the plasma concentration versus time curve (AUC (D0 - INF))
From baseline up to day 16
Pharmacokinetic parameter: time at which maximum plasma concentration occurs (Tmax)
From baseline up to day 16
Pharmacokinetic parameter: terminal elimination phase half-life (t(1/2))
From baseline up to day 16
Pharmacokinetic parameter: total clearance (CL/F)
From baseline up to day 16
Pharmacokinetic parameter: volume of distribution (Vd/F)
From baseline up to day 16
+5 more secondary outcomes

Study Arms (5)

Part 1 Cohort A

EXPERIMENTAL

Drug: ALE1Drug: Placebo

Part 1 Cohort B

EXPERIMENTAL

Drug: ALE1Drug: Placebo

Part 2 Cohort A

EXPERIMENTAL

Drug: ALE1Drug: Placebo

Interventions

ALE1Drug

Specified dose on specified days

Part 1 Cohort APart 1 Cohort BPart 1 Cohort CPart 2 Cohort APart 2 Cohort B

PlaceboDrug

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Participants are overtly healthy as determined by a medical evaluation
No concurrent medical conditions or significant medical history, in the opinion of the investigator.

Sponsors & Collaborators

Alesta Therapeutics B.V.
Industrylead
Alesta Therapeutics
Industrylead

Study Sites (3)

Universitätsklinikum Würzburg

Würzburg, 97074, Germany

RECRUITING

Dr. Lothar SeefriedCONTACT+49 931 803 3575 lothar.seefried@uni-wuerzburg.de

New Zealand Clinical Research

Grafton, Auckland, 1010, New Zealand

RECRUITING

Julia O'SullivanCONTACT+64 0800 788 3437

MeSH Terms

Conditions

Hypophosphatasia

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2025

First Posted

September 18, 2025

Study Start

September 30, 2025

Actual (reported)

Primary Completion

January 2027

Estimated

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (10)

Study Arms (5)

Part 1 Cohort A

Part 1 Cohort B

Part 2 Cohort A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Part 2 Cohort B

Part 1 Cohort C

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (10)

Study Arms (5)

Part 1 Cohort A

Part 1 Cohort B

Part 2 Cohort A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Part 2 Cohort B

Part 1 Cohort C

You may not qualify if:

Data Sharing

Source records

Locations