First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4

This study has been terminated.
(Proof of principle established with completed SAD part)
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT01374503
First received: June 14, 2011
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.


Condition Intervention Phase
Healthy Volunteers
Biological: ALX-0651
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase I, Single-centre, Randomised, Single-blinded, Placebo-controlled Single Ascending Dose Study, Followed by an Open-label Extension, Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of ALX-0651, Administered Intravenously to Healthy Male Volunteers

Further study details as provided by Ablynx:

Primary Outcome Measures:
  • Number of treatment emergent adverse events [ Time Frame: until 1 month after study drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • maximum plasma concentration (Cmax) of ALX-0651 [ Time Frame: from predose until 48 hours after study drug administration ] [ Designated as safety issue: No ]
    Plasma concentration of ALX-0651 will be determined at different timepoints between predose and 48 hours after the last study drug administration. The maximum plasma concentration (Cmax) of ALX-0651 will be derived from the resulting plasma concentration versus time plots.

  • CD34 positive cell count in blood [ Time Frame: from predose until 14 days after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALX-0651 Biological: ALX-0651
single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg
Placebo Comparator: Placebo Biological: Placebo
single or multiple i.v. administration

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers, aged >= 18 and <= 55 at screening.
  • Willing to consent to using an effective contraceptive method for at least 3 months after test substance administration.
  • Non-smokers, or ex-smokers abstinent from tobacco for at least 1 year.
  • Body mass index (BMI): 19 - 29 kg/m2 (extremes included).
  • Haematology and chemistry parameters within normal range or showing no clinically relevant deviations, as judged by the Medical Investigator. For haematology, haemoglobin and white blood cell (WBC) count must be within normal limits. For chemistry, calcium, alkaline phosphatase (ALP), (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and lactate dehydrogenase (LDH) must be within normal limits.
  • Normal electrocardiogram, showing no clinically relevant deviations, as judged by the Investigator. QTc <= 450 ms.
  • No history or presence of diseases of the kidneys, heart, lungs, liver, gastrointestinal tract or endocrine organs, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • No history of clinically relevant allergies.
  • Obtained, signed and dated informed consent.
  • Ability and willingness to comply with protocol requirements.

Exclusion Criteria:

  • Intake of any prescribed systemic or topical medication within 14 days prior to dosing.
  • Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
  • History of thrombosis.
  • Chronic infection or acute significant infection or fever within the last 5 weeks prior to the start of test substance administration.
  • Subjects with any abnormality of the spleen (confirmed by echography) or history of splenic disease, or subjects that underwent splenectomy in the past.
  • Blood donation (>500 ml) or a comparable blood loss within three months prior to the start of drug administration.
  • Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason, with special emphasis on eligibility for the aphaeresis procedure.
  • Participation in an investigational drug study within 60 days prior to drug administration, or within less than 6 times the terminal elimination half-life of the test substance used in the respective trial (whichever is longer).
  • Malignancy, or prior malignancy, with a disease-free interval of < 5 years after diagnosis and intervention, except curative treatment for non-melanoma skin cancer or resected carcinoma in situ.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374503

Locations
Netherlands
Groningen, Netherlands
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz, MD Ablynx NV
  More Information

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01374503     History of Changes
Other Study ID Numbers: ALX-0651-1.1/11
Study First Received: June 14, 2011
Last Updated: April 16, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on July 22, 2014