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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01374503
Recruitment Status : Terminated (Proof of principle established with completed SAD part)
First Posted : June 16, 2011
Last Update Posted : April 17, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Biological: ALX-0651 Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of treatment emergent adverse events [ Time Frame: until 1 month after study drug administration ]

Secondary Outcome Measures :
  1. maximum plasma concentration (Cmax) of ALX-0651 [ Time Frame: from predose until 48 hours after study drug administration ]
    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.

  2. CD34 positive cell count in blood [ Time Frame: from predose until 14 days after study drug administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01374503

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

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Responsible Party: Ablynx Identifier: NCT01374503     History of Changes
Other Study ID Numbers: ALX-0651-1.1/11
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: April 2012